FDA Starts Cyberegulation of Drug Information FDA regulators are now patrolling cyberspace. In December, the FDA told the Liposome Co. to stop using a "misleading" home page description of its fungal medicine, Abelcet. The FDA held a public meeting on Internet regulation in October and has solicited industry comments, but apparently isn't letting that process slow it down Oral Arguments in Tobacco Case Oral arguments are slated for Feb. 10 in the suits by tobacco and advertising interests against the Food and Drug Administration. The place: U.S. District Court for the Middle District of North Carolina in Greensboro. On Dec. 23, the plaintiffs filed a third reply brief in support of their motions for summary judgment. The brief argues that the FDA's restrictions on tobacco advertising violate the First Amendment in three ways: (1) The rules are not narrowly tailored; (2) they fail the "close look" test endorsed in the Baltimore billboard cases; and (3) they represent an unconstitutional ban on colors and images.

FDA Stonewalls on Kessler Deposition The Food and Drug Administration has defied a federal appeals court by refusing to allow Chairman David Kessler to be deposed in Washington Legal Foundation (WLF) v. Kessler. On Nov. 29, the U.S. Court of Appeals for the District of Columbia denied the FDA's writ of mandamus, thereby clearing the way for Kessler's deposition. But the FDA said it would refuse to let Kessler appear. WLF responded with a motion Jan. 10 seeking to have Kessler held in contempt. The motion also asks that the court deem portions of WLF's lawsuit to be admitted as fact, as a sanction against Kessler. WLF is seeking acknowledgment that the FDA does, in fact, have a final agency action in place to prohibit pharmaceutical and medical device makers from distributing medical textbooks to doctors.

Groups Sue BATF Over Alcohol Health Claims The Competitive Enterprise Institute (CEI) and Consumer Alert, a Washington-based consumer group, filed suit Oct. 29 against the Bureau of Alcohol, Tobacco, and Firearms over health claims on alcohol labels. In May 1995, CEI petitioned BATF to allow the following claim on labels and ads: "There is significant evidence that moderate consumption of alcoholic beverages may reduce the risk of heart disease." BATF failed to respond. CEI is asking the U.S. District Court for the District of Columbia to declare the ban unlawful under the First Amendment, and to order BATF to issue a rule allowing such health statements. The government was expected to file its response on Jan. 17.